Method for treating and maintaining skin

ABSTRACT

A method of topically using a combination of  Arnica montana  extract, bromelain,  Calendula  extract, daisy flower extract, grape seed extract, copper, and zinc contained in a carrier to promote skin health and healing.

CROSS-REFERENCED TO RELATED APPLICATIONS

This is a continuation application which claims the benefit ofnonprovisional application Ser. No. 15/186,288, now U.S. Pat. No.9,867,874, which was filed on Jun. 17, 2016, which in turn claims thebenefit of nonprovisional application Ser. No. 14/244,675, now U.S. Pat.No. 9,375,462, which was filed on Apr. 3, 2014, which in turn claims thebenefit of provisional application 61/807,881 which was filed on Apr. 3,2013 and is incorporated by reference.

FIELD OF THE INVENTION

The invention relates generally to skin care products and methods ofadministration.

BACKGROUND OF THE INVENTION

The skin is a complex organ consisting of several layers whichphysiologically act together to either maintain itself in a healthystate or to respond to injuries in the form of trauma and skindisorders. The epidermis is composed of four or five sublayers,depending on which part of the body is being covered. The dermis is thelayer beneath the epidermis and has two sublayers. The dermis alsocontains fibroblasts that produce collagen and elastin fibers. Thehypodermis is the deepest layer of the skin and attaches to the dermisby collagen and elastin fibers.

Healthy skin is characterized by a process generally known as epidermalrenewal in which the dead top cells flake off the stratum corneum over aperiod of weeks and are replaced by keratinocytes which are produced andpushed upwards by the other sublayers. The skin can be adverselyaffected by exposure to sunlight, overexposure to environmentalpollutants, poor nutrition, and trauma in the form of cuts, burns, andbruises. In addition to trauma, skin conditions can be caused bydisrupting the epidermal renewal process, altering the normalfunctioning of processes contained with the dermis, or changes to theblood vessels within the dermis.

The skin is capable of implementing healing processes depending on thetype and degree of the skin condition affecting it. Wounds resulting inloss of integrity of the skin, such as cuts and abrasions, willgenerally undergo healing in sequential phases, i.e., hemostasis,inflammation, proliferation, and maturation. Such wounds are repaired inpart by the migration of keratinocytes to close the wound. In addition,injured skin tissue is repaired by collagen deposition, collagenremodeling, and scar formation, The healing of other skin conditionsproceeds in a similar manner, involving the processes of collagenproduction, fibroblast production, fibrocyte production, fibroplasia,and angiogenesis.

Commonly-recognized products for promoting healthy skin or treating skinconditions either exert an overall effect such as hydration or areprimarily operative with respect to a single aspect of skin physiology.For example, moisturizers increase the hydration of skin by supplying anamount of water to the skin concurrent with an oil or grease to retardsubsequent loss of the water. Products such as coal tar and salicylicacid help to normalize the manner and rate at which the cells are shed.However, they can cause adverse effects such as redness and dryness.Steroid creams, such as hydrocortisone cream, lessen inflammation andpruritis. Products such as benzoyl peroxide and alcohol haveanti-bacterial effects but also tend to dry out the skin. Topicalimmunomodulators (TIMs) in the form of skin creams work by altering theimmune system response. As such, the prior art teaches products thatfail to enlist all the physiological pathways that are relevant to thehealing of skin, and in some cases, can cause other skin problems. Whatis needed is a composition and method of treatment that accelerates thehealing of skin conditions via concurrent physiological pathways.

SUMMARY OF THE INVENTION

The invention is a method that promotes the maintenance of healthy skinand expedites the healing of damaged skin by applying a combination ofArnica montana extract, bromelain, Calendula extract, daisy flower(Bellis perennis) extract, grapeseed extract, Aloe vera, copper, andzinc contained in a carrier. Topical application of the compositionresults in strengthening the epidermal barrier and accelerates thehealing of the skin beyond the body's unaided healing processes orpreviously recognized conventional treatments.

The composition influences the various physiological mechanisms thatmodulate the control mechanisms that regulate the balance between cellgrowth and cell death, while concurrently mitigating the adverse effectsof reactive oxygen species and fostering the removal of excess cellulardebris from the skin. One of the features of the invention is that ituses a composition that comprises several constituents that havemodulating properties with regard to apoptosis that ensure amulti-component base of compounds that contribute to its overallimmunomodulating capabilities. The constituents that contributeimmunomodulating properties to the invention that are believed to be themost dominant are grape seed extract, bromelain, and zinc. It is alsobelieved that Arnica Montana extract, Calendula extract, Aloe vera, andcopper components are contributors to apoptosis regulation. Thecombination of the constituents acts to balance the rates of cell growthand cell death and results in the orderly removal and renewal ofkeratinocytes. Of particular interest is trial work that shows that thecomposition induces the downregulation of hyperkeratotic cells.

The composition is formulated with extracts from several plant species,which bolsters the robustness of the immunomodulatory capability.Because the constituents have different bioavailabilities, dermalabsorption rates, and dermal penetration depths, the combination of theimmunomodulatory agents comprising the composition ensures a base thatis more biochemically complex than would be the case with a base thatcontains a single constituent having such effect. As a result, thecomposition has a greater effectiveness than would be expected byaggregating the individual constituents.

The method is effective for use on a broad population. The skins ofindividuals vary significantly in their ability to absorb and processspecific constituents. A significant factor is the normal individualgenetic variability among populations with regard to the enzymes andtransporters that carry out the physiologic functions of the skin.Likewise, the bioavailability of a substance can vary depending on thespecific nature of an individual's skin condition or status. Forexample, some constituents tend to be absorbed more or less efficientlydepending on whether the skin contains certain levels of fat orcollagen, which can vary over time. Similarly, skin is subject to levelsof stress which vary over time. For example, a skin that has recentlybeen exposed to high levels of ultraviolet-B radiation will be in adifferent immunomodulatory state than skin which has not been soexposed. A skin care composition that is based on the constituentsdescribed in this specification is able to ensure a level of uptake thatis capable of producing the desired physiologic effect throughout adiverse population.

By incorporating a broad base of immunomodulatory agents, thecomposition has a sustained effectiveness lasting at least several hoursbecause the kinetic characteristics of the constituents cover asignificant range of biochemical uptake, activity, and elimination. Thisovercomes a shortcoming of prior art immunomodulators because theabsorption and effective period of such immunomodulators are not alwayssufficient to sustain the desired action throughout the course of therelevant period. Combining immunomodulatory agents that have differentrates of metabolic processing thus enables the composition to workeffectively over a more extended period of time.

The method of using the composition has been found to improve cellrespiration and blood circulation, as well as having a marked effect inreducing inflammation and enhancing the production of collagen andelastin in the skin layers. It also promotes the regeneration of skincells and the removal of damaged proteins. These effects are caused inpart by regulating the production of transforming growth factor andvascular endothelial growth factor, and in regulating angiogenesis,which can be critical to healthy skin formation.

Another aspect of the method is the reduction of reactive oxygen species(ROS) such as those generated during exposure of the skin toultraviolet-B and other forms of radiation. These species have thecapacity to induce oxidative decomposition in the skin which in turnleads to the formation of toxic species as well as lipid peroxidation,both of which damage the skin and adversely affect its appearance.Another source of ROS are medical lasers that, while capable of beingused beneficially to treat various skin conditions, can produce ROS andcause detrimental effects such as erythema and pigmentation changes. Thetopical administration of antioxidants, in combination with the otheringredients of the composition, can significantly reduceerythema-associated redness and other expressions of oxidative skindamage. In particular, the grapeseed extract and daisy flower extractprovide substantial antioxidant content to the composition. The daisyflower extract can exert an additional effect by lightening the skin.

Bromelain promotes cellular debris removal. The extent to which thestratum corneum is composed of dead cells has a substantial effect onthe texture and appearance of the skin and the timely removal of excesscellular debris is beneficial in this regard. Bromelain also de-ages theskin by taking away the dull dead skin and reducing the appearance offine lines, enlarged pores, dullness, and wrinkles. Furthermore, theremoval of cellular debris has a positive effect on suppressingrecurrent outbreaks of acne by removing acne-producing bacteria fromskin pores. This function, albeit physiologically distinct fromimmunoregulatory mechanism, has an unexpectedly positive effect onreducing skin inflamation.

Other constituents may be added to the composition to augmenteffectiveness. For example, hyaluronic acid improves skin pliability,retards transepidermal water loss, and increases the skin'swater-retaining properties by acting as a humectant. Willow bark extractfrom Salix species encompasses salicylic acid, quercetin, and rutinwhich exert exfoliant and anti-inflammatory effects on the skin. Inaddition, willow bark extract has antimicrobial, antifungal, andantiviral properties that can promote protection of the skin frominfectious agents. Marsh mallow extract, derived from Altheaofficinalis, contains mucilagenous polysaccharides and antioxidantswhich are useful for reducing the irritation of skin tissue and forenhancing the barrier function of the skin. Date fruit extract, derivedfrom Phoenix species such as P. dactylifera, acts as an emollient andpromotes the delivery of the constituents of the composition into thedeeper epidermal layers.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is a method of using a composition, described inTable 1, that comprises constituents that simultaneously affect severalphysiological pathways with synergistic effect. The percentages listedadjacent to each constituent are the ranges of the constituents in termsof weight and the specific concentrations by weight in the formulationfor a skin care serum. Note that the expressed ranges should be viewedas relative proportions with respect to each constituent and do notnecessarily reflect the actual percentages contained in the formulatedproduct. It should also be recognized that the ranges are usefulstarting points for preparing a formulation and should not be viewed asrestrictions on the scope of ranges in which a formulation may beprepared. The composition may contain other constituents that, whileproviding a benefit to skin health, are optional. Examples of suchcompounds are magnesium, hyaluronic acid, and marsh mallow extract. Apreferred embodiment of the composition used in the invention is setforth in the column labeled “serum formulation” in Table 1.

TABLE 1 Formulations Range of Serum Constituent concentrationsFormulation Arnica montana extract: 0.50%-5% 1.0% Bromelain: 0.05%-5%0.25%  Calendula extract: 0.50%-5% 1.0% Daisy Flower extract: 0.50%-5%1.0% Grape seed extract: 0.50%-5% 1.0% Aloe vera:    5%-95%  20% WillowBark: 0.50%-5% 1.0% Marsh Mallow extract: 0.50%-5% 0.0% Date Fruitextract: 0.50%-5% 1.0% Zinc: up to 25% as zinc 1.0% Copper: up to 0.5%as copper 0.5% Magnesium: up to 5% as Mg 0.1% Hyaluronic Acid: 0.10%-1%1.0%

The composition encompasses several types of extracts. As a generalrule, it is desirable to use extracts in which the extracted material isat or near the point of maximum concentration. This is generally done byplacing the maximum amount of plant material that can reasonably beaccommodated by the extracting fluid, consistent with efficaciousextraction practices. The extracts can be made using any of theextraction methods that are known within the art and with extractantssuch as water, alcohol, or oils.

For the purposes the composition described above, the Arnica montanaextract can be made by extracting 250 ml of powdered dried Arnicaflowers with 1 liter of water, the Calendula extract can be made byextracting 400 grams of dried flowers with 1 liter of water, daisyflower extract can be made by extracting 100 grams of dried powderedflowers and pedicels with 1 liter at about 80° C., and date (Phoenixdactylifera) fruit extract can be prepared by extracting about 275 gramsof fruit in 1 liter of heated water. Grape seed extract is incorporatedinto the composition as a powder containing not less than 95% oligomericproanthocyanidin complexes (OPCs).

Bromelain, may be added to the composition as a powder that contains2000 gelatin-dissolving units per gram of powder. Willow bark can beadded in the form of powdered bark and marsh mallow can be added in theform of powdered leaves and roots. Hyaluronic acid can be added inpowder form as sodium hyaluronate. Aloe vera is an extract from the Aloevera plant may provided in the form of Aloe gel, which is produced byphysically separating the gel from the leaves of the plant. It may alsobe provided in the form of a powder. Zinc made added in the form anorganic or inorganic salt such as zinc picolinate, zinc acetate, zincgluconate, zinc monomethionine, zinc pyrithione, and zinc oxide.Similarly, copper can be incorporated into the composition in varioussalt forms including copper citrate, copper gluconate, and coppertripeptide. Magnesium may be incorporated in organic and inorganic saltforms such as magnesium aspertate.

Combinations of the ingredients described above can be incorporated intovarious forms of carriers such as tinctures, gels, powders, lotions,oils, serums, and creams. Such carriers are well known in the fields ofpharmacology, skin care products, and cosmetics. Examples of specificcarrier constituents include jojoba oil, olive oil, grapeseed oil, aloevera, and avocado oil.

Optionally, the ingredients can be incorporated into a concealer orcamouflage type of makeup. This embodiment of the composition isprepared by making a concealer base that contains pigments withsufficient opacity to hide skin conditions when the composition isapplied to the skin. Such pigments may include substances such astitanium dioxide, iron oxides, mica, magnesium stearate, talc, magnesiumcarbonate, zinc stearate, bismuth oxychloride, and boron nitride. Thepigments are held in a binder that can be prepared from one or moreingredients suitable for containing the active ingredients describedabove. Such ingredients may include water, petroleum distillates,beeswax, cyclomethicone, isostearyl neopentanoate, ozokerite, sorbitansesquioleate, sodium borate, tetrasodium EDTA, methylparaben,propylparabe, mineral oil, isopropyl palmitate, carnauba (coperniciacerifera) wax, allantoin, octyl palmitate, dimethicone, isopropyllanolate, polysorbate 80, imidazolidinyl urea, quaternium 15,caprylic/capric triglyceride, propylene glycol, dimethicone, cetylalcohol, cyclomethicone, glyceryl stearate, sorbitan stearate, peg-40stearate, PEG-100 stearate, methylchloroisothiazolinone,methylisothiazolinone, Helianthus annuus (sunflower) seed oil,cyclopentasiloxane, cyclotetrasiloxane, and triethanolamine. Theconcealer embodiment can be prepared in a variety of shades and colorsto look like a natural skin tone or to contrast with a particular typeof skin condition. For example, white can be used to offset theappearance of bruising and green and blue can counteract red patches onthe skin, such as those caused by rosacea.

The preferred regimen for the method is that the composition should beapplied topically to the skin at least once daily, although morefrequent application may be indicated depending on the nature and extentof the skin condition. The exact time of day for the application of thecomposition for promotion of general skin health is not critical but itis recommended that the composition should be applied at least five daysper week to ensure a sustained effect. The application interval can beincreased with beneficial effects on certain skin conditions andpreferably should be applied shortly after an event that may cause askin condition, or in any case, shortly after the appearance ofsymptoms.

As described previously, the composition acts to down regulate ormodulate the hyperproliferation of keratocytes and is useful incontrolling skin conditions in which hyperproliferation is manifested.Trial work has shown that the composition has a beneficial effect onskin comprising preneoplastic and neoplastic cells by reducing thepresence of such cells subsequent to topical application.

The method of using composition has general applicability for thetreatment of erythematous skin and atopic dermatitis, particularly skinthat is irritated or inflamed due to bacteria, viruses, fungi,allergens, insect bites, and sunburn. Notably, the method is usefulagainst bacterial infections of the type associated with acne or causedby Staphylococcus aureus or Streptococcus species. It is also usefulagainst fungal infections caused by Tinea corporas, Tenea pedis, andCandida species as well as viral infections such as those caused byherpes simplex viruses, human herpes virus-3, and molluscum contagiosumviruses.

The method of using the composition can prevent or reduce erythema ofthe skin if topically applied to the skin within 30 minutes of laserirradiation or a hypodermic injection. It is likewise effective whenapplied to skin irritated by urushiol which is an oil produced bymembers of the Toxicodendron genus of plants (e.g, poison ivy, poisonoak). In addition, the composition promotes healing of open skin woundssuch as abrasions, lacerations, and punctures; as well as closed skinhematomas.

As would be apparent to a person skilled in the art, a number ofvariations and modifications can be made to the method described abovewithout departing from the spirit and scope of the present invention.

The invention claimed is:
 1. A method of treating skin comprising thetopical application of a composition to skin having a condition selectedfrom the group consisting of: skin in which enhanced collagen productionis desired, skin that has been exposed to laser irradiation within theprevious 30 minutes, hyperkeratotic lesions, open wounds, hematomas,skin containing preneoplastic or neoplastic cells, urushiol-inducedcontact dermatitis, skin infected by viruses, skin infected by bacteria,and skin infected by fungi; wherein said composition is comprised ofeffective amounts of Arnica montana extract, bromelain, Calendulaextract, daisy flower extract, grape seed extract, zinc, and copper. 2.The method of claim 1 in which the following constituents that areformulated by weight according to the following ranges of parts: Arnicamontana extract, 0.5-5%; bromelain, 0.05%-5%; Calendula extract, 0.5-5%;daisy flower extract, 0.5-5%; grape seed extract, 0.5-5%; zinc (aszinc), 0.5-25%; and copper (as copper), 0.05% to 0.5%.
 3. The method ofclaim 1 in which the following constituents are formulated by weightsuch that the composition contains the following minimum percentages byparts: Arnica montana extract, 0.5%; bromelain, 0.05%; Calendulaextract, 0.5%; daisy flower extract, 0.5%; grape seed extract, 0.5%;zinc (as zinc), 0.5%; and copper (as copper), 0.05%.
 4. The method ofclaim 1, wherein the skin in need comprises skin in which enhancedcollagen production is desired.
 5. The method of claim 1 wherein theskin in need comprises areas of skin that have been exposed to laserirradiation and said composition is topically applied within 30 minutesof the termination of said laser irradiation.
 6. The method of claim 1wherein the skin in need comprises erythematous skin.
 7. The method ofclaim 1 wherein the composition is topically applied to skin havinghyperkeratotic lesions.
 8. The method of claim 1 wherein the skin inneed is skin having an open wound.
 9. The method of claim 1 wherein theskin in need is skin affected by a hematoma.
 10. The method of claim 1wherein the skin in need contains preneoplastic or neoplastic cells. 11.The method of claim 1 wherein the skin in need is skin infected by avirus, bacteria, or fungi.
 12. The method of claim 1 wherein the skin inneed is skin infected by viruses.
 13. The method of claim 1 wherein theskin in need is skin infected by bacteria.
 14. The method of claim 1wherein the skin in need is skin infected by fungi.
 15. The method ofclaim 1 in which the composition further comprises pigments withsufficient opacity to hide skin conditions when the composition isapplied to the skin.
 16. A method of enhancing collagen production inskin comprising the topical application of a composition which iscomprised of effective amounts of Arnica montana extract, bromelain,Calendula extract, daisy flower extract, grape seed extract, zinc, andcopper.
 17. The method of claim 16 in which the following constituentsare formulated by weight such that the composition contains thefollowing minimum percentages by parts: Arnica montana extract, 0.5%;bromelain, 0.05%; Calendula extract, 0.5%; daisy flower extract, 0.5%;grape seed extract, 0.5%; zinc (as zinc), 0.5%; and copper (as copper),0.05%.
 18. A method of promoting the maintenance of healthy skincomprising the topical application of a composition to skin wherein saidcomposition is comprised of effective amounts of Arnica montana extract,bromelain, Calendula extract, daisy flower extract, grape seed extract,zinc, and copper.
 19. The method of claim 18 in which the followingconstituents are formulated by weight such that the composition containsthe following minimum percentages by parts: Arnica montana extract,0.5%; bromelain, 0.05%; Calendula extract, 0.5%; daisy flower extract,0.5%; grape seed extract, 0.5%; zinc (as zinc), 0.5%; and copper (ascopper), 0.05%.